title: Safety and tolerability of ertapenem versus ceftriaxone in a double-blind study performed in children with complicated urinary tract infection, community-acquired pneumonia or skin and soft-tissue infection.
abstract: The carbapenem antibiotic ertapenem has been shown to be safe, well tolerated and effective in treating adults with complicated urinary tract infection, skin and soft-tissue infection and community-acquired pneumonia. In this study, we evaluated ertapenem for treating these infections in children in a randomised, double-blind, active-controlled clinical trial. The primary outcome was the incidence of clinical and laboratory drug-related serious adverse events (AEs). Children were randomised in a 3:1 ratio (ertapenem:ceftriaxone) stratified by index infection and age to receive ertapenem or ceftriaxone; 303 children received ertapenem and 100 children received ceftriaxone. The median duration of parenteral therapy was 4 days for both treatments. The most commonly reported drug-related clinical AEs during parenteral therapy were diarrhoea (5.9% ertapenem, 10% ceftriaxone), infusion site erythema (3% ertapenem, 2% ceftriaxone) and infusion site pain (5% ertapenem, 1% ceftriaxone). One child in each group reported a serious drug-related clinical AE. No serious drug-related laboratory AEs were reported. In children aged 3 months to 17 years, ertapenem was well tolerated and had a comparable safety profile to that of ceftriaxone.
authors.affiliation: Instituto de Atención Pediatrica, Universidad de Ciencias Médicas, Instituto Costarricense de Investigaciones Clinicas, San José, Costa Rica. aarguedas@iped.net
authors.forename: Adriano
authors.initials: A
authors.lastname: Arguedas
authors.forename: Jaime
authors.initials: J
authors.lastname: Cespedes
authors.forename: Francesc Aseni
authors.initials: FA
authors.lastname: Botet
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Blumer
authors.forename: Ram
authors.initials: R
authors.lastname: Yogev
authors.forename: Richard
authors.initials: R
authors.lastname: Gesser
authors.forename: Jean
authors.initials: J
authors.lastname: Wang
authors.forename: Joseph
authors.initials: J
authors.lastname: West
authors.forename: Theresa
authors.initials: T
authors.lastname: Snyder
authors.forename: Wendy
authors.initials: W
authors.lastname: Wimmer
mesh_terms: D000293:Adolescent; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002443:Ceftriaxone / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D017714:Community-Acquired Infections; D004311:Double-Blind Method; D000077727:Ertapenem; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008969:Molecular Sequence Data; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D017192:Skin Diseases, Bacterial / Q000188:drug therapy*; D018461:Soft Tissue Infections / Q000188:drug therapy*; D014552:Urinary Tract Infections / Q000188:drug therapy*; D047090:beta-Lactams / Q000009:adverse effects* / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D047090:beta-Lactams; D002443:Ceftriaxone; D000077727:Ertapenem